Identity
- Trade Name
- Stratus® CS FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory, semi-automated FDA UDI
- Device Name
- The Stratus® CS STAT Fluorometric Analyzer is a microprocessor controlled instrument that measures analytes in body fluids for in vitro diagnostic use. The instrument is intended for use by trained healthcare professionals in the clinical laboratory and point of care settings and is intended for the measurement of the following analytes: High Sensitivity Troponin-I (CTNI), CK-MB Mass (Creatine kinase. MB) (CKMB), Myoglobin (MYO), NT-proBNP (PBNP), D-dimer (DDMR), CardioPhase hsCRP (High Sensitiv FDA UDI
- Model / Reference
- 10444834 FDA UDI
- Description
- The Stratus® CS STAT Fluorometric Analyzer is a microprocessor controlled instrument that measures analytes in body fluids for in vitro diagnostic use. The instrument is intended for use by trained healthcare professionals in the clinical laboratory and point of care settings and is intended for the measurement of the following analytes: High Sensitivity Troponin-I (CTNI), CK-MB Mass (Creatine kinase. MB) (CKMB), Myoglobin (MYO), NT-proBNP (PBNP), D-dimer (DDMR), CardioPhase hsCRP (High Sensitiv FDA UDI
Identifiers
- Catalog Number
- 758000.901 FDA UDI
- Primary DI / UDI-DI
- 00842768024863 FDA UDI
- 510(k) Number
- K984067 FDA UDI
- FDA Product Code
- JHX FDA UDI
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory, semi-automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1215 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fluorescent immunoassay analyser IVD, laboratory, semi-automated
Stratus® CS by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluorescent immunoassay analyser IVD, laboratory, semi-automated.
- CELLTRACKS ANALYZER II — Menarini Silicon Biosystems Inc. · Class II
- ALFIS-3 — Boditech Med, Inc.
- CELLTRACKS ANALYZER II — Menarini Silicon Biosystems Inc. · Class II
- CELLTRACKS ANALYZER II — Menarini Silicon Biosystems Inc. · Class II
- CELLTRACKS ANALYZER II — Menarini Silicon Biosystems Inc. · Class II
- Stratus® CS STAT Fluorometric Analyzer Cannula — Siemens Healthcare Diagnostics · Class II
- Stratus® CS STAT Fluorometric Analyzer Cannula — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K984067 also covers:
- Stratus CS Acute Care CCRP CalPak — Siemens Healthcare Diagnostics
- Stratus® CS Acute Care™ CCRP TestPak — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Cannula — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Cannula — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Pipette Tips — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Rotors — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Sample Cups — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Waste Container — Siemens Healthcare Diagnostics
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI cc8f2e3a-b17f-4b12-8b62-287ebc53ab50 37 fields · synced May 30, 2026